Extraction device for extracting platelet-rich plasma from blood and manufacturing method

Abstract

The invention discloses an extraction device for extracting platelet-rich plasma from blood and a manufacturing method, and particularly relates to the technical field of clinical medicine. The extraction device comprises a pre-filled wash pipe injector and a sterile injector which are connected with the medical tee joint through a communicating piece; the pre-filled washpipe injector comprises a first container, the top of the first container is provided with a first sealing piece, and the first sealing piece is connected with a first communication port; the sterile syringe comprises a second container and a second adjusting piece, a second sealing piece is arranged at the top of the second container, and the second sealing piece is connected with a second communication opening. The manufacturing method comprises the following steps: extracting autoblood to the first container; and adding sodium citrate for anticoagulation, carrying out centrifugal treatment, connecting a sterile syringe with a pre-filled wash tube syringe, and extracting the plasma into a plastic test tube to obtain the platelet-rich plasma. The extraction device for extracting the platelet-rich plasma relates to a few structural components, and is simple to operate and high in extraction efficiency.

Description

Technical Field

[0001] The invention belongs to the technical field of clinical medicine, and specifically relates to an extraction device and a preparation method for extracting platelet-rich plasma from blood. Background Art

[0002] Platelet-Rich Plasma (PRP) is a platelet concentrate extracted from one's own blood. The main components of platelet-rich plasma are platelets, leukocytes and fibronectin. After activation, platelets can release a large amount of growth factors and cytokines. Leukocytes have anti-infection function, while fibronectin can provide cell scaffolds and have the effects of wound healing and tissue regeneration. It has gradually been widely used in many medical fields, including orthopedics, surgery, dentistry, ophthalmology, dermatology and wound healing.

[0003] However, there is no unified preparation method for PRP so far. The preparation principle of PRP is mainly to utilize the different sedimentation rates of various components in the blood, stratify the blood by centrifugation, and further concentrate it by centrifugation to obtain high-concentration platelet plasma. The centrifuged blood is divided into three layers from top to bottom, namely, the platelet-poor plasma (PPP) layer, the platelet-rich plasma layer and the red blood cell layer. However, in the prior art, the preparation method of PRP usually adopts multiple centrifugation, and the centrifuge tube needs to be replaced repeatedly in the process. This operation process not only increases the probability of contamination, but also easily causes platelets to be activated prematurely, so that the activity of the final PRP is reduced.

[0004] The PRP extraction devices currently used clinically are composed of many components, with a complex overall structure and cumbersome operation, which slows down the extraction speed of PRP. They also need to be transferred between multiple containers, increasing the chances of platelets being activated and contaminated, affecting the quality of platelet-rich plasma. Therefore, developing a simple and efficient extraction device for platelet-rich plasma is a technical problem that technical personnel in this field urgently need to solve. Summary of the invention

[0005] In order to solve the above problems in the prior art, the present invention provides an extraction device and a preparation method for extracting platelet-rich plasma from blood.

[0006] To achieve the above object, the present invention provides the following technical solutions:

[0007] One of the technical solutions of the present invention:

[0008] The present invention provides an extraction device for extracting platelet-rich plasma from blood, the extraction device comprising a prefilled flushing syringe, a sterile syringe and a medical three-way joint;

[0009] The prefilled flush syringe comprises a first container, the first container comprises a first chamber, a first sealing member is disposed on the top of the first container, and the first sealing member is connected to a first communication port;

[0010] The sterile syringe comprises a second container and a second adjusting member, the second container comprises a second chamber, a second sealing member is disposed on the top of the second container, and the second sealing member is connected to a second communication port;

[0011] The first communication port of the prefilled flushing syringe and the second communication port of the sterile syringe are connected to a medical three-way connection through a connecting piece.

[0012] Furthermore, there are a total of 3 sterile syringes, each of which includes a container, a connecting port, a chamber and an adjusting piece, namely the second container, the second connecting port, the second chamber, the second adjusting piece, the third container, the third connecting port, the third chamber, the third adjusting piece, the fourth container, the fourth connecting port, the fourth chamber and the fourth adjusting piece.

[0013] The second technical solution of the present invention:

[0014] A method for extracting platelet-rich plasma from blood, using any of the above-mentioned extraction devices for extracting platelet-rich plasma from blood, specifically comprising the following steps:

[0015] (1) using an intravenous infusion needle to draw autologous blood into the first container of the prefilled flush syringe;

[0016] (2) using a common syringe to extract anticoagulated blood and sodium citrate, adding the anticoagulated blood to the first container of the prefilled flush syringe and mixing with the autologous blood, and centrifuging the prefilled flush syringe;

[0017] (3) Take a sterile syringe, connect it to the prefilled flush syringe via a medical tee through a connecting piece, and then pull the second adjusting piece of the sterile syringe to extract the plasma in the prefilled flush syringe into a plastic test tube to obtain the platelet-rich plasma.

[0018] Beneficial effects: The present invention uses a prefilled flushing syringe to extract autologous blood, which can not only effectively prevent the blood from being contaminated and ensure the safety and purity of the blood, but also the prefilled flushing syringe is exquisitely designed and easy and quick to operate. The staff can quickly complete the blood extraction process without complicated preparations, thereby improving work efficiency. Moreover, in the present invention, the prefilled flushing syringe can also be used as a device for blood centrifugation. The prefilled flushing syringe containing blood is sealed with a plug, and then the push rod is broken off, and the excess tail end is removed and directly placed in a centrifuge for centrifugation. There is no need to replace other devices during the centrifugation process. After the centrifugation is completed, a sterile syringe is directly used to take out the plasma from the prefilled flushing syringe to prevent the blood from being contaminated when the equipment is replaced in the middle.

[0019] Furthermore, the mass concentration of sodium citrate for anticoagulation in step (2) is 2.5%;

[0020] The volume ratio of the sodium citrate for anticoagulation to the autologous blood is 10:(0.5-1), preferably 10:1.

[0021] Furthermore, the rotation speed of the centrifugal treatment in step (2) is 2500 rpm and the time is 3 minutes.

[0022] Furthermore, the step (3) is specifically as follows: taking a first sterile syringe, sealingly connecting it and the prefilled flush syringe to a connecting piece and a medical tee, then pulling the second adjusting piece of the first sterile syringe to draw out the upper layer of plasma in the prefilled flush syringe into a second container, and transferring 1 mL of the plasma into a plastic test tube;

[0023] Then take a second sterile syringe, seal it and the prefilled flush syringe to the connecting piece and connect it to the medical tee, then pull the third adjusting piece of the second sterile syringe to draw out the middle layer of plasma in the prefilled flush syringe into the third container, and transfer 1 mL of it to a plastic test tube;

[0024] Then, a third sterile syringe is taken, and it and the prefilled flush syringe are sealed and connected to the connecting piece and the medical tee, and then the fourth adjusting piece of the third sterile syringe is pulled to draw the lower layer of plasma in the prefilled flush syringe into the fourth container, and 1 mL of the plasma is transferred into a plastic test tube;

[0025] Finally, the number of platelet-rich plasma in each layer was measured, and the plasma layer with the highest platelet count was taken.

[0026] Beneficial effects: The present invention uses three sterile syringes to extract all the upper, middle and lower layers of plasma in the prefilled flush syringe, and then measures the number of platelets therein respectively, and takes the layer of plasma with the highest platelet number for treating the patient's own disease. This method simply and efficiently completes the extraction of platelet-rich plasma from autologous blood.

[0027] Furthermore, the prefilled flush syringe is sterilized under an alcohol lamp for 30 seconds before being connected to the sterile syringe.

[0028] Furthermore, the prefilled flush syringe is sealed with a plug before centrifugation to prevent the autologous blood in the first container from flowing out due to the large centrifugal force, and then the prefilled flush syringe is repeatedly inverted several times until the autologous blood and the anticoagulant sodium citrate are evenly mixed, and then the push rod is broken, the excess tail end is cut off and then placed in a centrifuge for centrifugal treatment.

[0029] Compared with the prior art, the present invention has the following beneficial effects:

[0030] The platelet-rich plasma extraction device studied in the present invention uses a prefilled flushing syringe and a sterile syringe to be combined and connected through a medical tee to complete the extraction of platelet-rich plasma from blood. It involves fewer structural components and is simple to operate, and is more suitable for promotion and application in this field.

[0031] In addition, the preparation method of the present invention is relatively simple and does not involve complicated container transfer, so platelets will not be activated or contaminated, thereby improving the extraction efficiency of platelet-rich plasma. It is a simpler, more efficient and lower-cost autologous platelet-rich plasma extraction device and preparation method. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required to be used in the embodiments are briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work:

[0033] Figure 1 A schematic diagram of the structure of an extraction device for extracting platelet-rich plasma from blood provided by the present invention;

[0034] Figure 2 A schematic diagram of the structure of a venous blood sampling device in an extraction device for extracting platelet-rich plasma from blood provided by the present invention;

[0035] Figure 3A schematic diagram of blood stratification in a prefilled flushing syringe after centrifugation in a method for extracting platelet-rich plasma from blood provided by the present invention;

[0036] Figure 4 A schematic diagram of the structure of extracting the upper plasma layer in a method for extracting platelet-rich plasma from blood provided by the present invention;

[0037] Figure 5 A schematic diagram of the structure of the middle layer plasma extracted from a method for extracting platelet-rich plasma from blood provided by the present invention;

[0038] Figure 6 A schematic diagram of the structure of extracting a lower layer of plasma in a method for extracting platelet-rich plasma from blood provided by the present invention.

[0039] Among them, 1. prefilled flush syringe; 2. sterile syringe; 3. medical tee; 10. first container; 11. first connecting port; 12. first sealing member; 13. connecting member; 111. first chamber; 20. second container; 21. second connecting port; 22. second sealing member; 211. second chamber; 212. second adjusting member; 30. third container; 31. third connecting port; 311. third chamber; 312. third adjusting member; 40. fourth container; 41. fourth connecting port; 411. fourth chamber; 412. fourth adjusting member. DETAILED DESCRIPTION

[0040] Now, various exemplary embodiments of the present invention are described in detail, and this detailed description should not be considered as a limitation of the present invention, but should be understood as a more detailed description of certain aspects, characteristics and embodiments of the present invention. It should be understood that the terms described in the present invention are only for describing specific embodiments and are not used to limit the present invention.

[0041] In addition, for the numerical range in the present invention, it is understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Each smaller range between the intermediate value in any stated value or stated range and any other stated value or intermediate value in the range is also included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded in the scope.

[0042] Unless otherwise indicated, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art. Although the present invention describes only preferred methods and materials, any methods and materials similar or equivalent to those described herein may also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials associated with the documents. In the event of a conflict with any incorporated document, the content of this specification shall prevail.

[0043] It will be apparent to those skilled in the art that various modifications and variations may be made to the specific embodiments of the present invention description without departing from the scope or spirit of the present invention. Other embodiments derived from the present invention description will be apparent to the skilled artisan. The present invention description and examples are exemplary only.

[0044] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0045] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0046] The specification of the prefilled flush syringe used in the embodiment of the present invention is 10mL;

[0047] The specifications of ordinary syringes and sterile syringes are both 5mL;

[0048] The specification of the intravenous infusion needle is 0.75×25TWLB;

[0049] Prefilled flush syringes, ordinary syringes, sterile syringes and intravenous infusion needles are all sterile, disposable and have been registered as Class III medical devices.

[0050] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the present invention is further explained in detail below with reference to the accompanying drawings and specific embodiments.

[0051] Example 1

[0052] Reference Figures 1 to 4 The present invention provides an extraction device for extracting platelet-rich plasma from blood, comprising a prefilled flushing syringe (1), a sterile syringe (2) and a medical three-way connection (3);

[0053] The prefilled flush syringe (1) comprises a first container (10), the first container (10) further comprises a first chamber (111), and a first sealing member (12) is arranged on the top of the first container (10), and the first sealing member (12) is connected to a first communication port (11);

[0054] The sterile syringe (2) comprises a second container (20) and a second adjusting member (212), wherein the second container (20) further comprises a second chamber (211), and a second sealing member (22) is arranged on the top of the second container (20), and the second sealing member (22) is connected to a second communication port (21);

[0055] There are three sterile syringes, each of which comprises a container, a communication port, a chamber and an adjusting member, namely, a second container (20), a second communication port (21), a second chamber (211), a second adjusting member (212), a third container (30), a third communication port (31), a third chamber (311), a third adjusting member (312), a fourth container (40), a fourth communication port (41), a fourth chamber (411) and a fourth adjusting member (412);

[0056] The first communication port (11) of the prefilled flush syringe (1) and the second communication port (21) of the sterile syringe (2) are connected to the medical tee (3) via a connecting piece (13).

[0057] Example 2

[0058] A method for extracting platelet-rich plasma from blood, using the extraction device of the above embodiment 1, the specific method comprises the following steps:

[0059] (1) taking a prefilled flush syringe (1), discarding the contents in the first chamber (111) thereof, and then connecting an intravenous infusion needle to the first connecting port (11) of the first container (10), and drawing autologous blood into the first chamber (111);

[0060] (2) The first connecting port (11) of the first container (10) after collecting blood is placed upward, and the installed intravenous infusion needle is removed. Then, a common syringe is used to extract sodium citrate for anticoagulation with a mass concentration of 2.5% and mixed with autologous blood in the first container (10), wherein the volume ratio of autologous blood to sodium citrate for anticoagulation is 10:1; the first sealing member (12) is installed, and the first container (10) is repeatedly inverted until the autologous blood and the sodium citrate for anticoagulation are evenly mixed, and then the push rod is broken and the excess tail end is cut off. The first container (10) of the sealed prefilled flush syringe (1) is placed in a centrifuge tube designed to match the shape and size of the first container (10) and centrifuged at a speed of 2500 rpm for 3 minutes. At this time, the contents in the first chamber (111) are plasma layer, buffy coat layer and red blood cell layer from top to bottom, as shown in FIG. Figure 3 As shown, after the centrifugation is completed, the prefilled flushing syringe (1) is placed in a specimen rack on a disposable pad in a clean bench, and then sterilized under an alcohol lamp for 30 seconds;

[0061] (3) Remove the first seal (12) on the first container (10), then take the first sterile syringe (2), remove the second seal (22) on the second container (20), seal the first connecting port (11) of the prefilled flush syringe (1) after removing the first seal (12) and the second connecting port (21) on the first sterile syringe (2) to the connecting member (13) and the medical tee (3), then pull the second adjusting member (212) of the first sterile syringe (2) to transfer the upper plasma layer in the first chamber (111) to the second chamber (211) of the second container (20) of the first sterile syringe (2) that does not contain any contents through the channel in the connecting member (13), and transfer 1 mL of the plasma layer to a plastic test tube, as shown in FIG. Figure 4 As shown; the plasma in the middle and lower layers remaining in the first chamber (111);

[0062] (4) The second container (20) containing the upper plasma layer is detached from the connecting piece (13) and replaced with a new second sterile syringe containing no contents, the third connecting port (31) of which is sealedly connected to the connecting piece (13), and the third adjusting member (312) of the second sterile syringe is pulled to transfer the middle layer of plasma in the first chamber (111) to the third container (30) of the replaced second sterile syringe, and 1 mL of the plasma is transferred to a plastic test tube, as shown in FIG. Figure 5 As shown; the lower layer of plasma remains in the first chamber (111);

[0063] (5) The third container (30) containing the middle plasma layer is detached from the connecting piece (13) and replaced with a new third sterile syringe containing no contents, the fourth connecting port (41) of which is sealedly connected to the connecting piece (13), and the fourth adjusting piece (412) of the third sterile syringe is pulled to transfer the lower plasma layer in the first chamber (111) to the fourth container (40) of the replaced third sterile syringe, and 1 mL of the plasma is transferred to a plastic test tube, as shown in FIG. Figure 6 As shown;

[0064] (6) Finally, measure the number of platelets in each layer of plasma, take the layer of plasma with the highest platelet count, and retain the amount to be used according to the patient's condition.

[0065] Performance Verification:

[0066] 20 blood samples of patients were drawn, and then each blood sample was divided into two parts, one of which was used to extract platelet-rich plasma using the method for extracting platelet-rich plasma from blood studied in Example 2, and the other was extracted using a common test tube. The results showed that the number of platelets extracted using the device of the present invention was higher than that extracted using a common test tube. Compared with this method, the extraction efficiency of platelet-rich plasma extracted by the extraction device studied in the present invention was 20% higher than that of the common test tube.

[0067] Any combination of operation steps for extracting PRP using the extraction device in this embodiment should fall within the scope of protection of the present invention.

[0068] The above description is only a preferred specific implementation manner of the present invention, and the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical scheme and inventive concept of the present invention within the technical scope disclosed by the present invention, and they should be covered by the protection scope of the present invention.

Claims

1. A device for extracting platelet-rich plasma from blood, characterized in that: The extraction device comprises a prefilled flushing syringe (1), a sterile syringe (2) and a medical three-way connection (3); The prefilled flush syringe (1) comprises a first container (10), the first container (10) comprises a first chamber (111), a first sealing member (12) is arranged at the top of the first container (10), and the first sealing member (12) is connected to a first communication port (11); The sterile syringe (2) comprises a second container (20) and a second adjusting member (212), the second container (20) comprises a second chamber (211), a second sealing member (22) is arranged on the top of the second container (20), and the second sealing member (22) is connected to a second communication port (21); The first communication port (11) of the prefilled flush syringe (1) and the second communication port (21) of the sterile syringe (2) are connected to a medical tee (3) via a connecting piece (13).

2. The device for extracting platelet-rich plasma from blood according to claim 1, characterized in that: There are three sterile syringes (2) in total, and each sterile syringe (2) comprises a container, a connecting port, a chamber and an adjusting member, which are respectively a second container (20), a second connecting port (21), a second chamber (211), a second adjusting member (212), a third container (30), a third connecting port (31), a third chamber (311), a third adjusting member (312), a fourth container (40), a fourth connecting port (41), a fourth chamber (411) and a fourth adjusting member (412).

3. A method for extracting platelet-rich plasma from blood, characterized in that: The method of extracting platelet-rich plasma from blood using the device according to any one of claims 1 to 2 specifically comprises the following steps: (1) using an intravenous infusion needle to draw autologous blood into the first container (10) of the prefilled flush syringe (1); (2) using a common syringe to extract anticoagulated blood and sodium citrate, adding the anticoagulated blood to the first container (10) of the prefilled flush syringe (1) and mixing with the autologous blood, and centrifuging the prefilled flush syringe (1); (3) Take a sterile syringe (2), connect it to the prefilled flush syringe (1) via a connecting piece (13) using a medical tee (3), then pull the second adjustment piece (212) of the sterile syringe (2) to extract the plasma in the prefilled flush syringe (1) into a plastic test tube to obtain the platelet-rich plasma.

4. The method for extracting platelet-rich plasma from blood according to claim 3, characterized in that: The mass concentration of sodium citrate for anticoagulation in step (2) is 2.5%; The volume ratio of the anticoagulant sodium citrate to the autologous blood is 10:(0.5-1).

5. The method for extracting platelet-rich plasma from blood according to claim 3, characterized in that: The centrifugal treatment in step (2) was performed at a speed of 2500 rpm for 3 min.

6. The method for extracting platelet-rich plasma from blood according to claim 3, characterized in that: The step (3) specifically comprises: taking a first sterile syringe (2), sealingly connecting it and the prefilled flush syringe (1) to a connecting piece (13) and a medical tee (3), then pulling the second adjusting piece (212) of the first sterile syringe (2) to draw out the upper layer of plasma in the prefilled flush syringe (1) into a second container (20), and transferring 1 mL of the plasma into a plastic test tube; Then, a second sterile syringe is taken, and the second sterile syringe and the prefilled flush syringe (1) are sealedly connected to the connecting piece (13) and the medical tee (3), and then the third adjusting piece (312) of the second sterile syringe is pulled to extract the middle layer of plasma in the prefilled flush syringe (1) into the third container (30), and 1 mL of the plasma is transferred into a plastic test tube; Next, a third sterile syringe is taken, and the syringe and the prefilled flush syringe (1) are sealed and connected to the connecting piece (13) and the medical tee (3), and then the fourth adjusting piece (412) of the third sterile syringe is pulled to draw the lower layer of plasma in the prefilled flush syringe (1) into the fourth container (40), and 1 mL of the plasma is transferred into a plastic test tube; Finally, the number of platelet-rich plasma in each layer was measured, and the plasma layer with the highest platelet count was taken.

7. The method for extracting platelet-rich plasma from blood according to claim 3, characterized in that: The prefilled flush syringe (1) is sterilized under an alcohol lamp for 30 seconds before being connected to the sterile syringe (2).

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